BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    WEAR SAFE (MALAYSIA) SDN. BHD.

    Reg #: 3006552561 · FEI: 3006552561 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    0
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    WEAR SAFE (MALAYSIA) SDN. BHD.
    Registration Number
    3006552561
    FEI Number
    3006552561
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    LOT 13726,JALAN HAJI SALLEH, BATU 5 1/4, OFF JALAN MERU
    City
    KLANG Selangor
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K223375

    Owner / Operator

    Firm Name
    WEAR SAFE (MALAYSIA) SDN BHD
    Operator Number
    9066807
    Address
    LOT 13726,JALAN HAJI SALLEH, BATU 5 1/4,, OFF JALAN MERU, KLANG, SELANGOR, 41050,
    City
    KLANG
    State
    Selangor
    Postal Code
    41050
    Country
    MY

    US Agent

    Business Name
    Parexel International
    Contact Name
    Sowmya Sony Janampally
    Address
    2520 Meridian Parkway, Research Triangle Park, Suite 200
    City
    Durham
    State
    NC
    ZIP
    27713
    Country
    US
    Email
    [email protected]
    Phone
    978 5456290

    Products

    Device Name Product Code
    Fentanyl And Other Opioid Protection Glove QDO
    Polymer Patient Examination Glove LZA
    Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs OPJ
    Medical Glove, Specialty LZC

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)